NEUWAVE LK20XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853719006388), received between Dec 20, 2018 and Apr 8, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL TRIAL THAT THE PATIENT EXPERIENCED A RE-ADMISSION BECAUSE OF PLEURAL EFFUSION (CHYLOTHORAX) AND OCCLUSION OF ARTERIAL BRANCH OF SEGMENT 6/7.

  Patient problems: Abdominal Pain; Insufficient Information; Pleural Effusion

  MAUDE report 11635228 ↗
• InjuryDec 20, 2018Malposition of Device

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE PATIENT HAS A SKIN BURN, ABDOMINAL WALL BURN, AND INTERCOSTAL BURN. THE PHYSICIAN WAS USING A TWENTY CM LENGTH PROBE AND STATES THAT THE PROBES DID NOT BACK OUT MORE THAN ONE TO TWO CM AND THE NEEDLES WERE HUBBED AT THE SKIN OF THE PATIENT. PHYSICIAN CONSULTED SURGERY AND DRESSED THE WOUND.

  Patient problems: Burn(s)

  MAUDE report 8184022 ↗